Continuous Versus Bolus Norepinephrine Administration to Treat Postinduction Hypotension

NCT07538388 | Recruiting

• 1 other identifier: 2025-101645-BO-ff
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 4

Brief Summary

INDUCT-Multi is a multicenter randomized trial investigating whether continuous, compared to bolus, administration of norepinephrine during induction of general anesthesia reduces postinduction hypotension in high-risk non-cardiac surgery patients.

Conditions

Postinduction Hypotension

Keywords

postinduction hypotension; non-cardiac surgery; norepinephrine; bolus; hypotension; continuous

Outcome Measures

Primary Outcomes (1)

• Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min)

  First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.

Secondary Outcomes (32)

• Area under a MAP of 60 mmHg (mmHg x min)

  First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.

• Area under a MAP of 50 mmHg (mmHg x min)

  First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.

• Area under a MAP of 40 mmHg (mmHg x min)

  First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.

• Area above a MAP of 100 mmHg (mmHg x min)

  First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.

• Area above a MAP of 110 mmHg (mmHg x min)

  First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.

Other Outcomes (4)

• Acute kidney injury

  Within the first 3 postoperative days

• Nonfatal cardiac arrest

  Within the first 3 postoperative days

• Myocardial infarction

  Within the first 3 postoperative days

Study Arms (2)

Continuous Norepinephrine Administration

EXPERIMENTAL

In patients assigned to continuous norepinephrine administration, norepinephrine will be administered continuously via a syringe infusion pump.

Procedure: Continuous Norepinephrine Administration

Bolus Norepinephrine Administration

NO INTERVENTION

In patients assigned to manual bolus norepinephrine administration, norepinephrine will be given manually in bolus doses.

Interventions

Continuous Norepinephrine Administration PROCEDURE

In patients assigned to continuous administration of norepinephrine, a syringe infusion pump will be prepared and connected to a peripheral or central venous catheter. The responsible anesthesiologist will start the norepinephrine infusion and adjust the infusion rate as necessary and may administer additional norepinephrine boluses via the syringe infusion pump if required.

Continuous Norepinephrine Administration

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We will include consenting patients ≥45 years scheduled for elective non-cardiac surgery under general anesthesia with planned continuous intra-arterial blood pressure monitoring with a radial arterial catheter and with at least two of the following risk criteria for developing acute kidney injury:
• Age ≥65 years
• ASA physical status III or IV
• Chronic arterial hypertension
• Diabetes mellitus requiring medication
• Intra-abdominal surgery
• Preoperative renal insufficiency (serum creatinine ≥1.2 mg/dL)

You may not qualify if:

• Pregnancy
• Cardiac arrhythmia
• History of intracranial hemorrhage or intracranial aneurysm
• Clinical indication for continuous norepinephrine infusion during induction of general anesthesia (e.g., severe aortic valve stenosis, coronary artery disease, or heart failure)
• Patients who are unable to understand, read, and provide informed consent in German

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (4)

Department of Anesthesiology and Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin

Berlin, Germany

NOT YET RECRUITING

Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University Duesseldorf

Düsseldorf, Germany

RECRUITING

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Department of Anaesthesiology, University Hospital LMU Munich

München, Germany

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Kristen K Thomsen, MD

CONTACT

+4940741070215; kr.thomsen@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 20, 2026
• Study Start: May 7, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)